Biopsy is the removal of tissue to examine it for signs of cancer or other disorders. Biopsies may be open (surgically removing tissue) or percutaneous (e.g. by fine needle aspiration, core needle biopsy or vacuum assisted biopsy). The biopsy site can be located via palpation, ultrasound or mammography.
Biopsy samples are obtained in a variety of ways using various medical procedures involving a variety of the sample collection devices. Examples of collection devices include those marketed under the tradenames MAMMOTOME (from DEVICOR MEDICAL PRODUCTS, Cincinnati Ohio), CELERO, ATEC AND EVIVA (all from HOLOGIC, Malborough Mass.), and FINESSE and ENCOR (all from BARD BIOPSY SYSTEMS, Tempe Ariz.).
Some of these systems collect the tissue sample in a closed container. U.S. Pat. No. 8,118,775 describes a closed tissue sample storage container that is designed to spatially segregate biopsy samples during the collection procedure. U.S. Pat. No. 7,572,236 describes a biopsy device with a closed container for collecting one or more samples. The container includes a basket for flushing away blood and other tissue debris from the specimens.
After the samples are removed from the patient, a tissue marker can be inserted into the tissue site to later relocate the site, if needed. For example, U.S. Pat. Nos. 6,270,464, 6,356,782, 6,699,205, 7,229,417 and 7,625,397 all describes tissue markers and methods for marking a biopsy site. It is desirable to be able to later relocate the position that the sample was taken from the tissue site by correlating information retained with the sample against the tissue marker.
After a tissue sample is collected, the sample is analyzed at a lab (e.g. a pathology lab, biomedical lab, etc.) that is set up to perform the appropriate tests (such as histological analysis) Often, collection of the sample, and analysis of the sample are performed at different locations and the sample must be transported from the collection location (e.g. hospital, clinic, etc.) to the lab (e.g. a pathology lab, biomedical lab, etc) for analysis.
Thus, after collection, the tissue samples are typically removed from the collection container and placed into another container for transport to a lab. Currently, the sample may simply be placed loosely in a specimen jar filled with the fixing agent or chemical (e.g., a solution of formaldehyde in water such as Formalin), which preserves the tissue sample for analysis and the specimen jar sealed for shipping. If multiple samples are collected, multiple samples from the same patient may be placed in the same jar for transportation. It is desirable to retain information collected during the tissue with each sample.
Once the tissue sample arrives in the lab, a series of steps may be performed for processing the tissue sample including:                1—Fixation of the sample to immobilize molecular components and/or prevent degradation. This is typically done with a fixing agent or chemical (e.g., a solution of formaldehyde in water such as formalin) shortly after sample collection.        2—Transferring the sample from the transportation jar to a processing cassette.        3—Infiltrating the sample with an embedding material, such as the paraffin wax.        4—Embedding the sample in the paraffin wax.        5. Sectioning using for example a microtome by slicing the sample into a plurality of thin sections (e.g., 2 to 25μ thick sections), prior to performing any staining analysis.        
Fixation is a process by means of which cell proteins are stabilized, and the process is normally performed using chemical fixatives. A good fixative is usually a fluid that will neither shrink nor swell the tissue, and more particularly will not dissolve its constituent parts, but will kill bacteria and render enzymes inactive. In addition, the solution should modify tissue constituents in such a way that they retain their form when subjected to treatment that would have damaged them in their initial state. The most commonly used fixative is formalin. In more recent years, alternatives to formalin (formaldehyde) have been proposed. WO 2004/093541 A1 teaches a formaldehyde-free, non-alcoholic tissue preservative composition comprised of ethanedial and a polar aprotic solvent in aqueous solution. Other non-formalin based fixatives include glutaraldehyde, alcoholic solvents, or acetic acid.
Typically after fixation, the sample is often removed from the container, placed in a cassette, and embedded in preparation for sectioning. Such sectioning of the sample often helps a medical professional properly assess the sample under a microscope (e.g. diagnose relationships between cells and other constituents of the sample, or perform other assessments). In order to properly section the sample, several steps are typically performed to embed the sample within a solid substrate. A commonly used solid substrate may include, for example, paraffin wax, which is used to hold the sample in position while also providing a uniform consistency to further facilitate sectioning with the microtome.
Under existing practices, this fixing, transferring, infiltrating, and embedding must all be done manually, and such manual handling of the sample can increase the likelihood of mis-identifying the sample, cross contaminating the samples, or losing part or all of the sample. Further, as multiple samples may be placed in the same jar, and each sample is merely loosely floating in the fixing agent, information about each sample, such as the orientation of the sample with respect to collection and, which sample was collected from which area of the patient (i.e., 2 mm from mass, 4 mm from mass, 6 mm from mass etc.) may be lost and unavailable to the medical professional when assessing the sample. Additionally, the numerous steps of manual manipulation can often increase the time that it takes to provide a proper assessment for each sample, once the sample is collected from the patient.
In the practice of histopathology and the preparation of cellular tissue materials for examination with the microscope, preparatory steps have an important impact on the availability of microscopic details that form the basis of proof for a diagnosis. For example, it may be critical to maintain orientation of the tissue sample during the preparatory phases. In addition, movement of the sample during preparation, either during collection and transfer to the lab or during laboratory processing in a tissue processing cassette, may damage the sample.
When tissue materials are collected, as with a tissue, there are specific criteria or judgments made of what might be suspicious of showing a disease process. The suspect area of the tissue is sampled with the intention of revealing a tissue diagnosis as the basis of a treatment method or approach. Contemporary methods of tissue biopsy and means for providing imaging of hidden suspect tumor targets deep within body cavities or organs, include, in the most modern approach, use of image guidance techniques, direct vision for surface lesions where a biopsy of tissue surfaces are harvested, needle through cut biopsies, aspiration biopsies of fluid, incision biopsies of surface lesions, remote skinny needle biopsies with ultrasound, or MRI, direct video or radio-graphic guidance to an imaging system. The resultant captured tissue may be solid, semi-solid, or liquid, as with cavity fluids containing traces of surface cells, to be determined benign, malignant, or inflammatory. In some instances, core needle biopsies are preferred.
It is of vital importance to orient the tissue in a fixed and precise way that will demonstrate anatomical relationship of importance to adjacent organ tissues or surfaces; all in relationship to the disease process. For instances, if a gastroenterologist or any other special-ologist visualized a suspicious area to biopsy, the ologist alone knows what was up or down, right or left, adjacent the stomach or other anatomical landmark.
WO0019897 teaches that typically prior to the fixation stage, a lab technician will place the tissue samples into the tissue cassette for processing. When the tissue samples are placed in the tissue cassette, the tissue samples are oriented with a specific surface facing up. Generally, the person retrieving the tissue sample after processing and before embedding the tissue sample, will place the surface facing up in the tissue cassette face down in the wax mold for embedding. Thus, maintaining the orientation of the tissue sample after the fixation stage is critical to ensuring that the tissue sample is oriented properly in the wax mold for sectioning.
For example, as taught in WO0019897 maintaining orientation is especially critical for vessel tissue samples where the section needs to be transverse, core biopsy tissue samples where the tissues should lie flat in the same plane, and gall bladder tissue samples where the tissue samples should be embedded on the edge. Critical to maintaining the orientation of a tissue sample may be maintaining proper position of all sides of a tissue sample, for example, face-up/face-down; left/right; or north/south.
Using a single container to maintain orientation of tissue samples from different locations sites may be difficult as tissue samples from different location sites are different shapes and sizes. That is, tissue samples are different shapes and sizes depending on the location from where the tissue sample was removed. For example, fine need aspiration biopsy tends to be very small pieces of tissue taken from the core of a fine needle, whereas, GI biopsy samples are characterized by a few small tissue pieces.
Consequently, it is desired to produce a container to retain, orient, and prevent cross contamination of a different types of tissue samples during the preparatory phases of a histological examination.
Also in consideration is the ischaemic time for pathology samples. That is, it is desirable to quickly preserve the tissue because the faster the tissue is preserved, the better the tissue is for IHC testing. It is further desirable to have a tissue container that allows for time, temperature, and PH monitoring. Also, it is desirable to have a container with an identifier or label that can be tracked and traced during transportation, such as a smart container.